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Cerebral Oxygenation in Total Hip Arthroplasty Patients

NCT ID: NCT02325154

Last Updated: 2024-12-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-08-31

Brief Summary

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We plan to investigate the relationship between hypotensive epidural anesthesia for hip arthroplasty and cerebral oxygen saturation.

Detailed Description

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The relationship between cerebral oxygenation and blood pressure in patients undergoing hypotensive epidural anesthesia has not been completely elucidated. Previous publications have demonstrated a low incidence of post-op cognitive dysfunction in patients undergoing hypotensive epidural anesthesia for total hip replacement (1-3) and that cerebral blood flow velocity is preserved as measured by transcranial Doppler (4). An earlier investigation by Dr. Yadeau demonstrated infrequent cerebral oxygen desaturation in spontaneously breathing patients undergoing shoulder arthroscopy, even in the presence of hypotension (4), but did not investigate outcomes in the cognitive domain or have a control group of patients undergoing surgery with general anesthesia. There has only been one study looking at cerebral oxygenation and hip surgery, which was performed in elderly patients with fractures. It demonstrated that patients with low pre-op regional cerebral oxygen saturation (rSO2) had higher incidence of delirium (5) but many of those patients had surgery under general anesthesia. Given the costs associated with post-op delirium, cognitive dysfunction and stroke (6) and based on the fact that previous publications from this institution have demonstrated both a low incidence of cognitive dysfunction and preservation of cerebral blood flow velocity using this anesthetic technique, we hypothesized that cerebral oxygen desaturation will not occur in this population.

Conditions

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Cerebral Oxygen Desaturation Post-operative Delirium

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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THA Patients

Patients undergoing unilateral total hip arthroplasty

Group Type EXPERIMENTAL

Cerebral Oximeter

Intervention Type DEVICE

Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.

Interventions

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Cerebral Oximeter

Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.

Intervention Type DEVICE

Other Intervention Names

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oximeter

Eligibility Criteria

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Inclusion Criteria

* Patients 18-80 years old undergoing unilateral total hip arthroplasty
* Hypotensive epidural anesthesia

Exclusion Criteria

* Contraindication to controlled hypotension and/or neuraxial anesthesia.
* Severe pulmonary hypertension or pre-op systolic blood pressure reading \>150 mm Hg
* Moderate to severe valvular stenosis.
* History of stroke, dementia, or post-op delirium
* Prior OSA diagnosis
* History of benzodiazepine use (regular use for longer than 3 months)
* Chronic renal or hepatic disease (renal failure, history of liver failure, cirrhosis)
* History of alcoholism or heavy alcohol intake (defined as averaging more than 3 drinks per night; recovery is OK)
* Parkinson's disease
* Severe chronic pulmonary disease
* Total anterior hip approach being used
* Hip resurfacing procedure
* Non-English Speaking\*

* Questionnaires being used to assess mental status are only validated in English.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sean Garvin, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status

Countries

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United States

References

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Williams-Russo P, Sharrock NE, Mattis S, Szatrowski TP, Charlson ME. Cognitive effects after epidural vs general anesthesia in older adults. A randomized trial. JAMA. 1995 Jul 5;274(1):44-50.

Reference Type BACKGROUND
PMID: 7791257 (View on PubMed)

Sharrock NE, Fischer G, Goss S, Flynn E, Go G, Sculco TP, Salvati EA. The early recovery of cognitive function after total-hip replacement under hypotensive epidural anesthesia. Reg Anesth Pain Med. 2005 Mar-Apr;30(2):123-7. doi: 10.1016/j.rapm.2004.12.005.

Reference Type RESULT
PMID: 15765453 (View on PubMed)

Rade MC, Yadeau JT, Ford C, Reid MC. Postoperative delirium in elderly patients after elective hip or knee arthroplasty performed under regional anesthesia. HSS J. 2011 Jul;7(2):151-6. doi: 10.1007/s11420-011-9195-2. Epub 2011 Feb 11.

Reference Type RESULT
PMID: 22754416 (View on PubMed)

Yadeau JT, Liu SS, Bang H, Shaw PM, Wilfred SE, Shetty T, Gordon M. Cerebral oximetry desaturation during shoulder surgery performed in a sitting position under regional anesthesia. Can J Anaesth. 2011 Nov;58(11):986-92. doi: 10.1007/s12630-011-9574-7. Epub 2011 Aug 25.

Reference Type RESULT
PMID: 21866430 (View on PubMed)

Papadopoulos G, Karanikolas M, Liarmakopoulou A, Papathanakos G, Korre M, Beris A. Cerebral oximetry and cognitive dysfunction in elderly patients undergoing surgery for hip fractures: a prospective observational study. Open Orthop J. 2012;6:400-5. doi: 10.2174/1874325001206010400. Epub 2012 Sep 3.

Reference Type RESULT
PMID: 22962570 (View on PubMed)

McDaniel M, Brudney C. Postoperative delirium: etiology and management. Curr Opin Crit Care. 2012 Aug;18(4):372-6. doi: 10.1097/MCC.0b013e3283557211.

Reference Type RESULT
PMID: 22732435 (View on PubMed)

Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Vaughn J, Nisman M. Cerebral oxygen desaturation events assessed by near-infrared spectroscopy during shoulder arthroscopy in the beach chair and lateral decubitus positions. Anesth Analg. 2010 Aug;111(2):496-505. doi: 10.1213/ANE.0b013e3181e33bd9. Epub 2010 May 27.

Reference Type RESULT
PMID: 20508134 (View on PubMed)

Other Identifiers

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2014-047

Identifier Type: -

Identifier Source: org_study_id